Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tasmar   
Auth. number : EU/1/97/044
Active substance : Tolcapone
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N04 - Anti-parkinson drugs
Pharmacological subgroup: N04B - Dopaminergic agents
Chemical subgroup: N04BX - Other dopaminergic agents
Chemical substance: N04BX01 - Tolcapone
(See WHO ATC Index)
Indication: Tasmar is indicated in combination with levodopa/benserazide or levodopa/carbidopa for use in patients with levodopa-responsive idiopathic Parkinson´s disease and motor fluctuations, who failed to respond to or are intolerant of other COMT inhibitors (see 5.1). Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a first-line adjunct therapy to levodopa/benserazide or levodopa/carbidopa (see 4.4 and 4.8). If substantial clinical benefits are not seen within 3 weeks of the initiation of the treatment, Tasmar should be discontinued.
Marketing Authorisation Holder: Meda AB
Pipers väg 2A, S-170 09 Solna, Sverige
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
28/08/1997 Centralised - Authorisation EMEA/H/C/132 (97)2757 of 27/08/1997
22/01/1998 Centralised - Variation EMEA/H/C/132/I/2 (1998)173 of 22/01/1998
20/07/1998 Centralised - Variation EMEA/H/C/132/I/3 (1998)2059 of 17/07/1998
16/12/1998 Centralised - Suspension of martketing authorisation EMEA/H/C/132/Z/5 (1998)4287 of 11/12/1998
24/01/2000 Centralised - Suspension of martketing authorisation EMEA/H/C/132/Z/6 (2000)40 of 20/01/2000
31/01/2001 Centralised - Prolongation of suspension EMEA/H/C/132/Z/7 (2001)92 of 29/01/2001
20/12/2001 Centralised - Prolongation of suspension EMEA/H/C/132/Z/8 (2001)4319 of 17/12/2001
09/01/2003 Centralised - Prolongation of suspension EMEA/H/C/132/Z/9 (2003)13 of 07/01/2003
16/01/2004 Centralised - Prolongation of suspension EMEA/H/C/132/Z/10 (2004)96 of 14/01/2004
02/09/2004 Centralised - Lift of suspension EMEA/H/C/132/Z/11 (2004)3389 of 31/08/2004
15/09/2004 Centralised - Variation EMEA/H/C/132/IA/13
Updated with Decision(2004)5622 of 22/12/2004
15/09/2004 Centralised - Variation EMEA/H/C/132/IA/12
Updated with Decision(2004)5622 of 22/12/2004
03/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/132/IA/15
04/01/2005 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/132/T/4 (2004)5622 of 22/12/2004
14/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/132/IA/16
14/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/132/IA/20
10/02/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/132/IB/18
10/02/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/132/IB/19
03/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/132/IB/17
16/03/2005 Centralised - Notification EMEA/H/C/132/N/22
Updated with Decision(2006)516 of 14/02/2006
21/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/132/II/21
20/07/2005 Centralised - Variation EMEA/H/C/132/IA/23
Updated with Decision(2006)516 of 14/02/2006
23/12/2005 Centralised - Variation EMEA/H/C/132/IA/25
Updated with Decision(2006)516 of 14/02/2006
23/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/132/IA/24
24/12/2005 Centralised - Variation EMEA/H/C/132/IB/26
Updated with Decision(2006)516 of 14/02/2006
16/02/2006 Centralised - Variation (2006)516 of 14/02/2006
08/08/2006 Centralised - Variation EMEA/H/C/132/II/27 (2006)3638 of 04/08/2006
16/03/2007 Centralised - Notification EMEA/H/C/132/N/28
Updated with Decision(2008)6006 of 09/10/2008
12/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/132/IA/29
27/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/132/IA/35
27/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/132/IA/34
04/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/132/IB/32
07/03/2008 Centralised - Variation EMEA/H/C/132/IA/36
Updated with Decision(2008)6006 of 09/10/2008
14/04/2008 Centralised - Notification EMEA/H/C/132/N/37
Updated with Decision(2008)6006 of 09/10/2008
14/10/2008 Centralised - Variation (2008)6006 of 09/10/2008
18/02/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/132/T/38 (2009)1102 of 13/02/2009
06/10/2009 Centralised - Renewal EMEA/H/C/132/R/39 (2009)7712 of 02/10/2009
17/08/2011 Centralised - Variation EMEA/H/C/132/IB/41
Updated with Decision(2012)1920 of 19/03/2012
08/02/2012 Centralised - Variation EMEA/H/C/132/IB/42
Updated with Decision(2012)1920 of 19/03/2012
21/03/2012 Centralised - Variation (2012)1920 of 19/03/2012
19/10/2012 Centralised - Variation EMEA/H/C/132/IB/43
Updated with Decision(2012)7905 of 29/10/2012
01/11/2012 Centralised - Variation (2012)7905 of 29/10/2012
05/03/2013 Centralised - Variation EMEA/H/C/132/IB/44
Updated with Decision(2014)1619 of 05/03/2014
16/02/2014 Centralised - Notification EMEA/H/C/132/N/48
Updated with Decision(2014)1619 of 05/03/2014
07/03/2014 Centralised - Yearly update (2014)1619 of 05/03/2014
22/07/2014 Centralised - Renewal EMEA/H/C/132/R/47 (2014)5249 of 18/07/2014
14/08/2015 Centralised - Variation EMEA/H/C/132/IA/52